study of abt-510 (thrombospondin analogue) in patients with advanced head and neck cancer

Conditions: Head and Neck Cancer

Summary: the goals of this clinical research study are to see how individuals with advanced head and neck cancer respond to treatment with the new drug thrombospondin (abt-510) and to learn how effective it is in destroying cancer cells. the safety of abt-510 and the effect abt-510 has on cells in the body will also be studied.

this is a phase ib/ii, single-center, open-label study designed to assess the safety, tolerability, pharmacokinetics, and biologic efficacy of abt-510 (thrombospondin). participants will be patients with incurable head and neck cancer. patients will begin at a fixed dose level of thrombospondin subcutaneously twice daily. cycles of treatment are 28 days (4 weeks). patients will be treated with thrombospondin until progression of tumor or toxicity.

Eligibility criteria:
inclusion criteria: * patient has histologically proven squamous cell carcinoma of the head and neck that is not amenable to curative therapy, including radiation or surgery (including surgery following induction chemotherapy or chemo-radiation). * patient's tumor is biopsy accessible. * patient has a karnofsky performance status \>/= 70. * patient has adequate bone marrow function: white blood count (wbc) \>/= 3,000 cells/mm3, absolute neutrophil count (anc) \>/= 1,500 cells/mm3, platelet count \>/= 100,000 cells/mm3, hgb \>/= 9.0 g/dl. * patient has adequate liver function: total bilirubin level \ /= 2.5 g/dl. * transaminases (sgot and/or sgpt) may be up to 2.5 \* upper limit of normal (uln) if alkaline phosphatase is \ 1.5 \* uln and alkaline phosphatase \> 2.5 \* uln are not eligible for this study. * patient has serum creatinine \< 2 mg/dl * patient has signed a written informed consent. * patient may have received any number of prior chemotherapeutic regimens for recurrent or metastatic disease. * the subject must not be pregnant or breastfeeding. all subjects (male and female) should practice contraception (e.g., barrier, hormonal, intrauterine device \[iud\]) or abstain from sexual intercourse while in the study and for up to two months following completion of therapy. * the subject is able to self-administer or has a caregiver who can reliably administer subcutaneous (sc) injections. * patient \>/= 18 years of age. exclusion criteria: * no biopsy accessible tissue. * patient has received prior radiation therapy to biopsy site within the past 3 months. (patient may have received palliative radiation within the past 2 weeks, but not to the biopsy site.) * patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair patient's understanding of the informed consent. * patient requires total parenteral nutrition with lipids. * patient has a history of uncontrolled heart disease including congestive heart failure, angina at rest, myocardial infarct in the last 6 months, uncontrolled hypertension with systolic blood pressure (bp) \>160 or diastolic bp \>90, systolic blood pressure (bp) \<90 or symptomatic hypotension, or symptomatic or potentially life-threatening tachycardia, bradycardia or arrhythmia. * pregnant women and women who are currently breast-feeding may not participate in this study. all women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study. * serious infection or other intercurrent illness requiring immediate therapy. * the subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). the subject has a recent history of (within 4 weeks from study day 1) or currently exhibits other clinically significant events of bleeding. * if subject is receiving therapeutic anticoagulation therapy, low dose anticoagulation for catheter prophylaxis will be permitted; pt/ptt must be within normal limits. * the patient has a history of or currently exhibits central nervous system (cns) metastasis. brain magnetic resonance imaging (mri) within 28 days of enrollment is required to confirm the absence of cns metastases. * patient has received chemotherapy or biologic therapy within 3 weeks of registration.

Keywords: head and neck cancer thrombospondin analogue abt-510 antiangiogenic agent lung skin thyroid